Radiation Dose in Humans From Orally Administered Tc99m-Heparin

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study of a new agent used for evaluation of inflammation in the GI tract. This agent is investigational and thus is being studied to determine appropriate dosing and administration in both normal controls (i.e. people without gastrointestinal complaints) and patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in their bodies with a certain cell called an eosinophil).

The study will test whether the radiolabeled agent will bind to the inflammation of eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which shows the striking deposition of eosinophil granule proteins is not available.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• 10 patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population

• 7 controls (subjects without GI symptoms and known GI disease)

Exclusion Criteria:

• bleeding diathesis or contraindication to esophageal biopsies

• severe sleep apnea

• incarceration

• pregnancy

• inability to lie flat for 2 hours

• history of bleeding disorder

• Use of steroids

• Breast feeding

• Allergy to heparin or history of severe reaction to heparin

• allergy to mucomyst or severe asthma